The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

Not Applicable

Completed

• Conditions: Growth of Term Infants

• Registration Number: NCT01897922
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-09
• Study First Posted: 2013-07-12
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

• Singleton, 12-16 days of age at randomization
• Term infant with birth weight of a minimum of 2500 grams
• Solely formula fed
• Signed Informed Consent and Protected Health Information

Exclusion Criteria

• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or formula intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight measured at each study visit	3.5 months

Secondary Outcome Measures

Name	Time	Method
Medically-confirmed adverse events collected throughout the study period	3.5 months
Recall of infant formula intake at each study visit	3.5 months
Recall of stool consistency measured at each study visit	3.5 months
Parental Study Product Assessment Questionnaire completed at Study Visit 2	once
Head circumference measured at each study visit	3.5 months
Recall of gastrointestinal tolerance measured at each study visit	3.5 months
Body length measured at each study visit	3.5 months

Trial Locations

Locations (22)

Birmingham Pediatric Associates; 🇺🇸 Birmingham, Alabama, United States

Greenvale Pediatrics Hoover; 🇺🇸 Birmingham, Alabama, United States

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States

Pediatrics East - Alabama Clinical Therapeutics; 🇺🇸 Pinson, Alabama, United States

The Children's Clinic of Jonesboro, P.A.; 🇺🇸 Jonesboro, Arkansas, United States

Arkkansas Pediatric Clinic; 🇺🇸 Little Rock, Arkansas, United States

Norwich Pediatric Group, P.C.; 🇺🇸 Norwich, Connecticut, United States

Children's Research, LLC; 🇺🇸 Altamonte Springs, Florida, United States

Children's Medical Associations; 🇺🇸 Plantation, Florida, United States

Deaconess Clinical Research; 🇺🇸 Evansville, Indiana, United States

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